期刊
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
卷 75, 期 19, 页码 2403-2413出版社
ELSEVIER SCIENCE INC
DOI: 10.1016/j.jacc.2020.03.008
关键词
aspirin; bleeding; diabetes mellitus; thrombosis; ticagrelor monotherapy
资金
- AstraZeneca
- Amgen
- Aralez
- Bayer
- Biosensors
- Boehringer Ingelheim
- BristolMyers Squibb
- Chiesi
- Daiichi-Sankyo
- Eli Lilly
- Janssen
- Merck
- Sanofi
- CeloNova
- CSL Behring
- Eisai
- Gilead
- Idorsia Pharmaceuticals
- Matsutani Chemical Industry
- Novartis
- Osprey Medical
- RenalGuard Solutions
- Scott R. MacKenzie Foundation
- Abbott
- Boston Scientific
- Medtronic
- Angel Medical
- Janssen Pharmaceuticals
- Johnson Johnson
- Portola Pharmaceuticals
- Bristol-Myers Squibb
- Corindus
- Ancora
- CSI
- ShockWave
- Devax
- Infraredx
- Pfizer
- Zoll
- DSI
- Novartis Pharmaceuticals
- OrbusNeich
- PLC/RenalGuard
- Abbott Vascular
BACKGROUND P2Y(12) inhibitor monotherapy with ticagrelor after a brief period of dual antiplatelet therapy can reduce bleeding without increasing ischemic harm after percutaneous coronary intervention (PCI). The impact of this approach among patients with diabetes mellitus (DM) remains unknown. OBJECTIVES The purpose of this study was to examine the effect of ticagrelor monotherapy versus ticagrelor plus aspirin among patients with DM undergoing PCI. METHODS This was a pre-specified analysis of the DM cohort in the TWILIGHT (Ticagrelor With Aspirin or Alone in High-Risk Patients after Coronary Intervention) trial. After 3 months of ticagrelor plus aspirin, patients were maintained on ticagrelor and randomized to aspirin or placebo for 1 year. The primary endpoint was Bleeding Academic Research Consortium 2, 3, or 5 bleeding. The composite ischemic endpoint was all-cause death, myocardial infarction, or stroke. RESULTS Patients with DM comprised 37% (n = 2,620) of the randomized cohort and were characterized by more frequent comorbidities and a higher prevalence of multivessel disease. The incidence of Bleeding Academic Research Consortium 2, 3, or 5 bleeding was 4.5% and 6.7% among patients with DM randomized to ticagrelor plus placebo versus ticagrelor plus aspirin (hazard ratio: 0.65; 95% confidence interval: 0.47 to 0.91; p = 0.012). Ticagrelor monotherapy was not associated with an increase in ischemic events compared with ticagrelor plus aspirin (4.6% vs. 5.9%; hazard ratio: 0.77; 95% confidence interval: 0.55 to 1.09; p = 0.14). In the overall trial population, there was no significant interaction between DM status and treatment group for the primary bleeding or ischemic endpoints. CONCLUSIONS Compared with ticagrelor plus aspirin, the effect of ticagrelor monotherapy in reducing the risk of clinically relevant bleeding without any increase in ischemic events was consistent among patients with or without DM undergoing PCI. (Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention [TWILIGHT]; NCT02270242) (J Am Coll Cardiol 2020;75:2403-13) (c) 2020 by the American College of Cardiology Foundation.
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